Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma

Prostate Cancer Clinical Trial

Official title:

A Randomized, Phase II Trial of Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin Administered Either Weekly or Every Four Weeks in the Treatment of Hormone Refractory Prostate Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193193
• Other study ID #: SCRI GU 10
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: August 3, 2010
• Start date: August 2000
• Est. completion date: February 2007

Study information

• Verified date: July 2010
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

In this trial we will investigate how this three-drug regimen may be improved, both with respect to efficacy and toxicity, by making some modifications in the dosing and schedule in the treatment of patients with hormone refractory prostate cancer.

Description:

Upon determination of eligibility, patients will receive:

Paclitaxel + Estramustine + Carboplatin

Patients will receive weekly paclitaxel and low-dose estramustine, in combination with carboplatin administered either weekly r every four weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2007
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adenocarcinoma of the prostate not curable with local treatment

• Disease progression while receiving hormonal therapy

• Measurable or evaluable disease

• Previous treatment with a maximum of one prior chemotherapy regimen

• ECOG performance status 0, 1, or 2.

• Adequate bone marrow, liver and kidney function

• Able to comprehend the nature of this study and give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Age < 18 years

• History of treatment for an invasive malignancy within five years

• Significant heart disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Paclitaxel

• Estramustine

• Carboplatin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Secondary	Toxicity
Secondary	Overall survival